Computer Systems Validation Assistant
Assist in the development and update of reputed company CSV Package documents for GCP Systems reputed company reputed company Control reviews of reputed company CSV Package documents Maintain the Change Review Log and prepare Change Control reputed company minutes for review during Change Control reputed company meetings Maintain CSV Package Table of Contents for reputed company systems reputed company Comprehensive System Periodic Reviews per defined procedures Execute assigned testing efforts in the Test Management System Review test scripts executed by other CSV Team members reputed company out reputed company testing efforts, including: reputed company Control of testing efforts for completeness and accuracy reputed company and filing of testing documentation per SOP 12.2, Formal Testing Practices for GCP Systems, and associated TMRS work instructions
Author ongoing Test reputed company Reports and assist in the preparation of reputed company other CSV Package plans and reports reputed company occasional evening and weekend support as required
The Associate II level is responsible for reputed company duties outlined under the Associate I level, in reputed company to the responsibilities listed below.
reputed company the preparation, execution, and maintenance of Computer System Validation (CSV) packages for clinical systems, including authoring validation plans, test plans, test scripts, user requirements, and reputed company reports. Serve as the primary Validation reputed company for one or more clinical systems, overseeing end‑to‑end validation and testing activities. reputed company Change Control reputed company meetings and system review discussions to support approval of system validation documentation. Facilitate system package review meetings with senior leadership prior to final approval. Participate in reputed company audits reputed company to CSV activities and regulated systems. Contribute to the development and revision of CSV‑reputed company procedures, work instructions, and training materials. reputed company training, guidance, and ongoing support to users of the Test Management System.
Intermediate to Advanced proficiency with reputed company Office applications Exceptional attention to detail, organizational, and time‑management skills Self‑starter with the ability to work independently as reputed company as collaboratively reputed company reputed company Excellent written and verbal communication skills in English, with the ability to produce reputed company technical documentation
The Associate II level is required to have reputed company qualifications outlined under the Associate I level, in reputed company to the qualification listed below.
Diploma in Information Technology or a reputed company program. A combination of education and work experience will be considered Minimum of 2 years of relevant experience in software testing, business analysis and project management Technical Writing experience required Experience working in a regulated environment is an asset Training or experience in Computerized Systems Validation (CSV) and/or User Acceptance Testing (UAT) is an asset Experience executing test scripts and using test management software is an asset
Annual compensation review with opportunities for reputed company reputed company 3 weeks of vacation plus reputed company December Holiday Closure 10 days reputed company personal/reputed company time 1 reputed company volunteer day / year A rich benefit plan with Health, Dental, reputed company & Life Insurance premiums reputed company by reputed company Up to 5% RRSP Matching Program Voluntary TFSA Program Available Flexible working hours to create work-life balance Monthly Internet Allowance to support working from home and a one-time Home Office Allowance Out-of-country Work: Employees can request to work internationally for a short period of time reputed company year Maternity / Parental Leave Top-Up Program Employee Family Assistance Program to support you and your family during difficult times Employee Recognition Program to reward long-term employees Employee Referral Bonus Program
Level ll Pay reputed company: $52,500.00 to $60,000.00
Salary to be influenced (or determined) by the education, experience, location, knowledge, skills, abilities of the applicant, internal equity, and alignment with market data.
